Why Merck did not recall Vioxx

Several people have written to us expressing outrage at the behavior of Merck. The common question asked is How could a company be so greedy that tens of thousands of people were dying and the company continued to aggressively market Vioxx prior to its recall?

While the Vioxx example is not only a criminal act, it is also unethical by any standards. Particularly for a drug company. What Merck did in case of Vioxx is absolutely unforgivable, but to put Merck's behavior in context, let us review the dynamics of the pharmaceutical industry. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), as presented in their Pharmaceutical Industry Profile 2004 (Washington, DC: PhRMA, 2004), while extremely profitable, pharmaceutical industry has many challenges:

• On average, it takes scientists, physicians, engineers, and other researchers between 10 and 15 years and costs more than $800 million to do the research and testing to bring a new medicine to patients.
• In 2003, members of PhRMA spent an estimated $33.2 billion on pharmaceutical R&D—a sizeable increase over the previous year.
• The industry is one of the largest employers of scientists in the United States and its success or failure relies heavily on their ability to make breakthroughs.
• Pharmaceutical research company scientists earned FDA approval for an average of 32 new medicines a year over the past decade.
• Only 3 out of every 10 marketed Rx drugs produce revenues that match or exceed average R&D costs.
• Under current law, generic drug manufacturers can already infringe unexpired patents in order to prepare their copies for Food and Drug Administration approval and the market, and can—in an increasing number of instances—enter the market with their copies years before patents expire.

What does it mean?

Pharmaceutical companies are under tremendous pressure to come up with blockbuster drugs (over $1 billion in sales), like Vioxx, to pay for R&D of other failed drugs. The window of opportunity is extremely short, normally just about five years. A firm has to maximize its return on blockbuster drug by doing whatever it takes during that window.

What was Merck thinking in case of Vioxx?

A lot of what was going on at Merck can be easily explained by the very nature of the drug industry, but a few things that can be hypothesized are as follows:

• If Merck could stop establishment of a strong correlation between Vioxx and deaths of tens of thousands of cardiovascular complications in arthritis patients, there was no way to prove that something was wrong with Vioxx. There were two sources from such research could come:
  (a) FDA, but it is already controlled by drug industry insiders. To make sure that the FDA maintained a hands-off policy towards Merck (and the drug industry), Merck (and others in the drug industry) pumped millions of dollars in campaign contributions to the Republican party. (Related article: Vioxx recall shows FDA hijacked by drug industry)
  (b) Think tanks, research institutions, medical experts, etc., who did publish the research that raised doubts about Vioxx, but according to Dr. Eric Topol, Merck was pursuing an aggressive attack strategy under which any study that raised doubts about Vioxx was countered by Merck scientists and paid consultants who were bombarding medical journals arguing about the safety of Vioxx.

Recommended article: Vioxx recall is an example of risk management by Merck